DRUG TRIALS ASSIGNMENT ESSAY ON: DRUGS ARE BIOCHEMICAL EFFECTS
Drugs are natural, endogenous, man-made chemical substance which brings a biochemical effects on the body and is used for the diagnosis, prevention, cure and treatment of disease. Pharmacology is the concerned with the science of drugs (Tokens 2005). It includes the understanding about the sources of different drugs; their absorption, distribution, metabolism till the excretion of the drug from the body. The drug being developed in the pharmaceutical laboratories is subjected to extensive laboratory testing mostly carried out in research and development divisions(R and D) of the laboratories with good clinical practices (GCP) and then the potential new drug developed is ready for pre-clinical evaluation and clinical evaluation ( Van, C 2004,p. 453). clinical trial is done to test better and new ways of improving health and well-being of a person. The trial quires a lot of expertise and team work. A protocol requiring the type of people, the ethics ,being aware of the consequences by the subjects, procedures, dosages, medications response measurements, experimental dosages and statistically sound design plan and analysis of data by statistical methods(Bishop 2010)
Article 1____________________________________________________________________
A Double Bind randomised study on Minocycline for the treatment of early-phase Schizophrenia
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2,500Clinical Study on Minocycline drug in schizophrenia treatment
>Full text online
>Journal Article
>Published dates 2008-2012
>English
296
This drug trial was conducted by Emotion-cognition research centre, Shalvata mental health care in Israel was this was displayed in PubMed database and clinicaltrials.gov website with full text online. First clinical trials was entered into the database, to narrow the search, clinical trials on schizophrenia was entered ,to further search for a specific topic, minocycline drug was selected to understand its effects for the treatment of schizophrenia
Overview:
Schizophrenia is a disorder in humans characterized by disturbances in thoughts, volition, perception, psychomotor, social behaviour and the sense of self. Although patients suffering start from a point of normalcy following onset to some degree of clinical deterioration. This is evident by the increasing severity and persistence of cognitive impairment, psychotic and negative symptoms, cognitive impairment, and diminished functional and social capacity. The drug Minocycline is a second-generation derived from tetracycline. It has beneficial effects in the neurologic disorders and may inhibit members of caspase family, NOS (bring about neuroprotective effects in the brain) and the MAP kinase pathway. The safety record of Minocycline and its ability to penetrate the blood-brain barrier are well known. Therefore, if this drug will be found to have neuroprotective effect in schizophrenia it may be a novel therapy. Antipsychotics have a limited effect of schizophrenia, it depends on the cognitive and negative deficits. Recent research findings from pre-clinal studies done in animals and clinical studies done in man suggests for the potential treatment in Schizophrenia. The mechanism of action is the minocycline effect on the glutametergic system, through the blocking of nitric oxide-induced neurotoxicity and inhibition of nitric oxide synthase. Other proposed mechanism includes effects of this drug on the dopamine system and the inhibition activity of the microglial activities (Levkovitz, Y et.al 2009).
Aim:
To study the efficacy of the drug minocycline for reducing the cognitive and negative symptoms during the early-phases of schizophrenia for the treatment of negative and cognitive symptoms.
Sample:
Seventy Early-phase schizophrenia patients in age from 18-35 years were tested and out of which 54 patients were randomly administered minocycline in ratio of 2:1in 200mg/d concentration.
Methods:
A randomized, Phase III, longitudinal, double-blind, placebo controlled group was designed and the effects were monitored for 6months.54 patients was allocated randomly minocycline in a ratio of 2:1 in 200mg/d dose. Also 14 days, prior to the study, all patients were treated with atypical anti-psychotic medication such as olanzapine ,risperidone , clozapine in 200–600 mg/d chlorpromazine-equivalent doses. Cognitive, functional and clinical assessments were conducted with scale for assessment of negative symptoms (SANS) as the prime outcome study (Levkovitz Y et.al 2009).
Findings:
The drug Minocycline was tolerated well with little adverse reaction. It showed a favourable effect on negative symptoms which is evident from clinical global impression scale and SANS. A similar trend was also found for mainly in cognitive executive functioning such as cognitive shifting, cognitive planning and working memory.
Discussion
The effect of minocycline is seen for early stage of schizophrenia but the drug’s effects are not evaluated yet for late stages of this disease.
Conclusion :
Minocycline drug treatment was connected with improvement of cognitive executive functioning and negative symptoms both associated with activities in frontal-lobe .The findings support the beneficial effect of add-on minocycline drug in the early-phase schizophrenia.
Article 2:__________________________________________________________________
Risk Score Alerts for Chest Pain Care
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1,400Study of risk scores alerts on improvement primary care for chest pain
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>Published dates 2008-2012
>English
188
This drug trail was conducted by Division of General Medicine and Primary Care, Brigham and Women’s hospital. This research article was displayed in PubMed database and clinicaltrials.gov website with full text online. First clinical trials was entered into the database, to narrow the search, clinical trials on chest pain was selected, to further search for a specific topic, the study on risk scores alert on improvement in primary care was selected to understand its monitoring in the chest pain.
Overview:
The assessment of chest pain is challenging in the primary care office, with many patients suffering from acute myocardial ischemia and other risks infarction due to missed diagnosis. This research study will provide physicians examining the patients with chest pain with providing computerized alerts and new strategies that can separate low risk with high risk patients and provide individualized treatment methods. This is based on Framingham Risk Score (at least 10%) which identifies patients with chest pain in the primary care setting and give reliable results for high risk patients. This study will evaluate and implement electronic risk alerts to risk stratify chest pain patients and give information in context of electronic health record to clinicians with a goal of improving safety and quality. This study helps in determining how the treatment can be optimized through use of electronic support strategy, while also documenting the cost implications (Sequist ,D 2012).
Aim:
Can risk scores alerts improve primary care for chest pain?
Sample:
Phase III, randomized, controlled trial conducted among 292 primary care professionals caring for 7,083 adult patients with chest pain with no history of any cardiovascular disease.
Methods:
Clinicians or Health care professionals receive regular alerts from the electronic health record during patient visiting for chest pain. Primary measures included the administration of aspirin, electrocardiogram performance for high risk patients and avoidance of cardiac stress testing in low risk patients. One alert recommended performance of electrocardiogram taken and aspirin administration for high risk patients where the Framingham Risk Score (FRS) ≥ 10%) and a second alert suggested against performance of cardiac stress testing for less risky patients having FRS< 10%( Sequist, TD 2012)
Results and Discussion:
About 81% of patients with chest pain were categorized as low risk. Acute myocardial infarction occurred among 26 (0.4%) patients, more prevalent among high risk patients compared to low risk patients (1.1% versus 0.2%). Among high risk patients, there was no difference between the control groups and intervention in rates of administering aspirin (20% versus 18%) and conducting electrocardiograms (51% versus 48%).Among low risk patients, there was no difference between control group and intervention in the rates of cardiac stress testing (10% versus 9%).
Conclusion:
Primary care management of chest pain is suboptimal for both high and low risk patients. Electronic alerts do not increase risk-appropriate care for these patients.
Article 3:_________________________________________________________________
Galantamine drug in the Treatment of Alzheimer’s disease
Aim:
To assess the clinical effects of galantamine in patients with alzheimer’s disease and to inspect potential moderators.
Overview:
Alzheimer’s disease is a loss of brain function affecting memory, thinking and behavior (Gage Centage learning 2005) which gets worse over time. Galantamine being an experimental drug is analysed for the treatment of Alzheimer’s disease in United States. Results from previous trial suggests that this drug is not a cure for the disease but it may improve the cognitive performance of the patients this this disease. Galantine increases the acetylcholine amount by inhibiting the enzyme that breaks down acetylcholine and stimulating nicotinic receptors that release more neurotransmitters. Acetylcholine is a neurotransmitter whose deterioration effects thought processes in the brain. Being a competitive specific and reversible acetylcholinesterase inhibitor and an allosteric modulator at nicotinic cholinergic receptor sites bringing nicotinic neurotransmission. The recent clinical trials show cognitive, global benefits for patients suffering from alzheimers. Also this drug was approved in 29 countries (Olis, J 2002).
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2,400Study on galantamine drug in the treatment of Alzheimer’s
>Full text online
>Journal Article
>Published dates 2008-2012
>English
148
This trial was conducted by the Adult and Geriatric Treatment and Preventative Interventions Branch in National Institute of Mental Health, USA. This research article was displayed in PubMed database and clinicaltrials.gov website with full text online and searched using the keywords galantamine into the database .
Methods:
Phase III ,randomised trials was conducted in double-blind, parallel-group and was selected for the comparisons of galantamine with placebo and its effects were observed for 4 weeks duration for people with Alzheimer’s disease. Data were extracted independently and pooled appropriately as possible. The pooled average differences and odds ratios (95%CI) were estimated.
Results and Discussion:
Seven trials were recognized that met criteria with six trials being Phase II or III trials. One of 13 weeks, two were of 12 weeks duration, one of 5 months and two of 6 months duration. Overall, galantamine showed significant treatment effects of 3-6 month at daily doses of 16-32 mg. For trials of 6 months duration (5-months to 29 weeks), only doses of 8mg/d failed to be associated with statistically significant benefit (16mg: OR 2.25; 95% CI 1.6 – 3.3; 24mg: OR 2.0; 95%CI 1.5 -2.5; 32mg: OR 1.9; 95%CI 1.4 – 2.5).For global ratings, trials of 3 months duration with doses of 24-32mg/d (Odds Ratio (OR) 2.3; 95%CI 1.3 – 3.9) and 36mg/d (OR 3.4; 95%CI 1.2 – 9.5) were statistically significant in treatment. For cognitive function over 6 month’s duration: at 16mg/d, improvements were measured and seen. The two 3-month trials with ADAS-Cog data also showed statistically significant improvement. Both observed cases (WMD 3.8; 95%CI 0.3 – 7.3) and intention-to-treat analyses using the Disability Assessment of Dementia scale gave statistically significant results for daily doses of 32mg for 6 months duration. Galantamine consistently failed to show statistically significant treatment effects at doses of 8mg/day. With dosage increase Galantamine’s adverse reaction showed gastrointestinal symptoms .Overall, participants treated with galantamine at all doses for 3 months were more likely to discontinue that were those given placebo. Participants treated with galantamine at doses of 24-32 mg/d for 6 months were more likely to discontinue in most trials than were those treated with lower doses or placebo, with 32mg/d being associated with significantly higher withdrawal rates than was 24mg/d. However, in the one trial with a slower rate of titration the discontinuation rate was not significantly greater than placebo for the 16 mg/day dose.
Conclusion:
Galantamine’s effect on more severely impaired people has not yet been assessed. A consistent positive effects for galantamine fewer seen for trials of 3 months, 5 months and 6 months duration. In addition, although there was not a statistically significant dose-response effect, benefits associated with doses above 8mg/d. Galantamine’s safety is same as cholinesterase inhibitors with regard to cholinergically mediated gastrointestinal symptoms. No information is available on adverse events that occurred less than 5% of the time. It appears that doses of 16 mg/d were best tolerated in the single trial where medication was titrated over 4-week periods, and because this dose showed statistically identical efficacy with higher doses, it is probably preferable initially (Olis, J 2002). Longer-term use of galantamine has not been evaluated in a controlled manner.
Conclusion: ______________________________________________________________________
Drug after passing through the clinical trials has to be approved by FDA (Food and Drug administration), MHRA (Medicines and Healthcare products Regulatory Agency) and sponsors need to be satisfied with the data regarding the efficacy and safety, a “package insert” is set for the approval by MHRA or FDA. After the careful analysis of the data ,the licence is granted and is marketed for the public general use. Later the drug is patented by the pharmaceutical company in order to recoup the drug development costs and also preventing other pharmaceutical organization from selling. After the patent is got other companies can duplicate and market the drug at a lower price.
Big pharmaceutical companies have an aim of developing drugs and bringing it to the markets for huge profits, which is a multimillion dollar business. A company on an average requires$359 million to develop a new drug or treatment (California Biomedical Research Association n.d.) .Key areas of attention are mental illness, AIDS, cancer, diabetes, vaccines, central nervous system disorders, pain, Infectious and respiratory disorders. Clinical trials are designed to evaluate the effectiveness and safety of a different dose that is usually used, to assess the effectiveness and safety of drugs with patients having a special conditions, to compare whether the new device medication is more effective than the standard medication or therapy and assess the effectiveness and safety of already marketed medication for a new significant or negative indication. Thorough ongoing clinical trials are critical for effective and safe treatments .Thus it is imperative to support biomedical research for people safety and health benefits.
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